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U.S. Department of Health and Human Services

Class 2 Device Recall Sedecal SPHF 4.0 Portable XRay System

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 Class 2 Device Recall Sedecal SPHF 4.0 Portable XRay Systemsee related information
Date Initiated by FirmOctober 27, 2003
Date PostedOctober 29, 2003
Recall Status1 Terminated 3 on March 24, 2004
Recall NumberZ-0001-04
Recall Event ID 27549
510(K)NumberK020436 
Product Classification unknown device name - Product Code IZL--
ProductSedecal SP-HF 4.0 Portable X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) Spain
Code Information serial #PK10058
FEI Number 1000139935
Recalling Firm/
Manufacturer		 Sedecal USA, Inc
2910 N Arlington Heights Rd
Arlington Heights IL 60004-1551
For Additional Information ContactMr. Devan Moser
847-394-6960
Manufacturer Reason
for Recall		A minimum source-skin-distance of less than 30 cm and not identifying the tube manufacturer on the tube housing label resulted in the SP-HF-4.0 Portable Systems not complying with the U.S. Federal performance standard.
FDA Determined
Cause 2		Other
ActionAn 'Important Safety Notice' dated 10/27/03 was sent to the one direct account on the same date, informing them of the non-compliances with the performance standard and requesting them to call Sedecal at 800-920-9525 to arrange for the modification of the x-ray unit at no cost to the user.
Quantity in Commerce1 unit
DistributionVermont
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IZL--
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